Redefining evidence in rehabilitation: Time to move beyond the RCT bias

Abstract

Background

Randomised controlled trials (RCTs) are traditionally considered the gold standard of evidence in rehabilitation research. However, in physiotherapy, the complexity, individual variability, and contextual nature of interventions limit the applicability and external validity of RCT findings.

Objective

This editorial aims to critically examine the dominance of RCTs in rehabilitation science and to advocate for a pluralistic evidence model that better reflects the realities of patient-centred practice.

Methods

A narrative and critical analysis of the limitations of RCTs in physiotherapy was conducted, highlighting methodological and epistemological challenges such as lack of blinding, standardisation constraints, exclusion of complex patients, and limited ecological validity. Alternative approaches—including pragmatic trials, N-of-1 designs, mixed-methods research, and real-world data registries—are discussed.

Results

The analysis reveals that overreliance on RCTs leads to internally valid but clinically disconnected findings, suppresses clinical reasoning, and undervalues patient-centred outcomes. Pragmatic and context-sensitive methodologies provide more meaningful insights into rehabilitation effectiveness, safety, and patient experience.

Conclusion

To advance rehabilitation science, evidence hierarchies must be redefined to embrace methodological pluralism. Rather than discarding RCTs, the field should complement them with diverse study designs that prioritise contextual fit, clinical reasoning, and patient-centred outcomes. This paradigm shift is essential for bridging the gap between research and practice and for ensuring that rehabilitation evidence truly serves patients.